I attended the Annual Conference of the Food and Drug Law Institute held in Washington, D.C. on May 2-3, 2019, a truly informative and well-orchestrated conference that included sessions discussing all manner of issues facing industries and attorneys representing their interests from medicines, medical devices, food, cosmetics, tobacco, cannabis, including topics I found most compelling for my practice—animal drugs and animal-related innovations.

Norman E. ‘Ned’ Sharpless, MD, Acting Commissioner of Food and Drugs – Food and Drug Administration and FDA Chief Counsel, Stacy Cline Amin gave remarks at the conference respectively available here and here.

In Dr. Sharpless’ remarks, the first made in his new role, he included issues facing animal populations, including the promising field of genomic alteration and the role of FDA’s Center of Veterinary Medicine in ensuring “that the genetic modification is safe to the animal, that it does what it’s supposed to do, and, if in a food-producing animal, that it is safe to eat.”

Chief Counsel Amin also addressed innovations related to genome-edited animals [and plants].  She also discussed the impact of the Department of Justice’s “Brand Memo” which limits the use of agency guidance documents in affirmative civil enforcement cases.  As stated therein,

[o]n November 16, 2017, the Attorney General issued a memorandum (“Guidance Policy”) prohibiting Department components from issuing guidance documents that effectively bind the public without undergoing the notice-and-comment rulemaking process. Under the Guidance Policy, the Department may not issue guidance documents that purport to create rights or obligations binding on persons or entities outside the Executive Branch (including state, local, and tribal governments), or to create binding standards by which the Department will determine compliance with existing statutory or regulatory requirements.

The Guidance Policy also prohibits the Department from using its guidance documents to coerce regulated parties into taking any action or refraining from taking any action beyond what is required by the terms of the applicable statute or lawful regulation.

This memo may help circumvent deference by courts under Chevron, to agency interpretation of laws set forth in guidance documents.

As stated in the memo,

effective immediately for affirmative civil enforcement (“ACE”) cases, the Department may not use its enforcement authority to effectively convert agency guidance documents into binding rules.

Likewise, Department litigators may not use noncompliance with guidance documents as a basis for proving violations of applicable law in ACE cases.

More to come on the information provided at this conference for animal, food, drug, and cosmetic law practitioners.